Efficacy and safety of Chinese herbal medicine on blood glucose fluctuations in patients with type 2 diabetes mellitus: A protocol of systematic review and meta-analysis

BACKGROUND: As one of the major chronic diseases that seriously threaten human health, type 2 diabetes mellitus (T2DM) has become a global public health problem. Blood glucose fluctuation is a risk factor independent of hyperglycemia. At present, the measures to treat blood glucose fluctuations in patients with T2DM are insufficient in effectiveness and safety. Medical practice and clinical studies have proved that Chinese herbal medicine has obvious advantages in reducing blood glucose fluctuations. In this systematic review, we will assess the efficacy and safety of Chinese herbal medicine in the treatment of blood glucose fluctuations in patients with T2DM. METHODS: We will search related literature of PubMed, Embase, Cochrane Library, Web of Science, China Biology Medicine Database, China National Knowledge Infrastructure, China Science and Technology Journal Database, and Wanfang Database, and will manually search grey documents such as literature such as conference articles and references articles. Eligible randomized controlled trials will be screened based on inclusion criteria, and data extraction, risk of bias assessment, publication bias assessment, subgroup analysis, and quality assessment will be performed. Review Manager version 5.3 software and stata version 13 software will be used for data analysis. Each process is independently conducted by 2 researchers, and if there is any objection, it will be submitted to the third researcher for resolution. RESULTS: This study will provide evidence for the efficacy and safety of Chinese herbal medicine in the treatment of blood glucose fluctuations in patients with T2DM. Outcome measures include mean amplitude of glycemic excursions, 24 hours mean blood glucose, standard deviations of blood glucose, mean of daily differences, coefficient of variation, glucose time in range, fasting blood glucose, 2 hours postprandial blood glucose, glycated hemoglobin, HOMA-β, HOMA-IR, quality of life questionnaire, traditional Chinese medicine syndrome score, and adverse event.